CONSELHO NACIONAL DE ÉTICA PARA AS CIÊNCIAS DA VIDA
OPINION
18/CNECV/97
on
The European Parliament’s
and Council of the European Union’s Bill
Proposing a Directive for
THE JURIDICAL PROTECTION OF BIOTECHNOLOGICAL INVENTIONS
(COM (95) 661; Dec.13, 1995)
1. General Considerations
The Bill we are asked to analyse was submitted following a rejection
by the European Parliament, on the 1st of March, 1995, of a previous Bill with
the same title, on which the National Council of Ethics for the Life Sciences
(CNECV) had already emitted an Opinion on the 6th of April, 1994
(7/CNE/94).
Thus, this ethical reflection by the CNECV on the subject of the
juridical protection of biotechnological inventions is not original.
For that reason, and also due to imperative reasons of time relating to
the recent start of a new mandate, the CNECV shall address to that earlier
Opinion the ethical reflection on the principles involved, where it was more
deeply elaborated – for that reflection still stands as regards its
considerations and conclusions.
Nevertheless, because we have to do with a new Bill, and because it
contains perspectives and enunciates now formulated for the first time, we
shall outline a comparative analysis of the main ethical aspects found in the
new Bill and reflect upon them.
2. The ethical aspects of the new Bill and its present necessity
An Opinion requested of the European Union’s Economic and Social
Committee states that “biotechnology, naturally, presents a challenge to
R. Prof. Gomes Teixeira, Edifício da PCM, 3º andar, sala 321,
tel. 392.76.88, fax 392.76.15
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CONSELHO NACIONAL DE ÉTICA PARA AS CIÊNCIAS DA VIDA
industry and the economy, generating employment and commercial
opportunities” 1.
In effect, registration of a patent guarantees the monopoly on the
commercialisation of an invention for a period of 20 years, so as to
compensate the inventor for the intellectual and economic investment made.
As referred in the previous reflection by the CNECV, the necessity to
adopt a common juridical framework in the countries of the European Union
as regards the application of the patent rights of biotechnological inventions
arises, in the first place, from the absence of such a framework in the various
countries of the Union.
In fact, not only national but also supra-national legislations in the
Union failed to foresee that, with the evolution of science and technology,
the right of exclusive use of biological material would become possible, as it
is today; just as they did not equip themselves with a common and uniform
instrument of application that might impede the possible divergence of criteria
from country to country in the evaluation of biotechnological inventions filed
for patenting. And although, undoubtedly, the jurisprudence of the European
Agency of Patents might be invested with harmonising such criteria, the truth
is that, pursuant to the Munich Convention, that same jurisprudence may be
over-ruled by a national judge. Accruing to this is the non-existence of a
common interpretation relative to patent pre-requisites such as the “noncontrariety to public order” or the “respect for moral decency”.
2
As a direct consequence of this absence of a common orientation,
European scientific research and investments to finance it are discouraged,
which fragilises its competitiveness in the face of research done outside the
European Union.
On the other hand – and most significantly from an ethical perspective
– without joint dispositions to safeguard ethical aspects concerning the
human body, there can be no guarantees of its protection.
Culminating with this presupposition, the ethical aspects of the
previous Bill became perhaps the principal theme of debate, and sufficient
cause to reject that Bill. Thus, the main reason for the failure of the first Bill
submitted is said to be its essentially technical and juridical character and its
deficient approach of some problems, especially those of an ethical nature.
1
Cf. the Opinion of the Economic and Social Committee with the same title as the present one -i.e. Proposta de
directiva (CE) do Parlamento Europeu e do Conselho relativa à protecção jurídica das invenções
biotecnológicas (96/C 295/03).
2
Cf. the Code of Industrial Property and the European Convention on Patents, and other relevant Conventions.
R. Prof. Gomes Teixeira, Edifício da PCM, 3º andar, sala 321,
tel. 392.76.88, fax 392.76.15
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CONSELHO NACIONAL DE ÉTICA PARA AS CIÊNCIAS DA VIDA
In truth, the absence of clarification of what was meant by “the human
body or elements of the human body as such” – one of the conditions
considered to exclude patent rights – and particularly of the expression “as
such”, raised much doubt over the admissibility of the right of exclusivity in
the use of the human body or of its natural constituent elements. In fact, the
differentiation between invention (patentable) and discovery (non patentable)
was not defined in that enunciate in unequivocal manner.
Amendments in the new Bill conducive to an ethical approach.
The text of the new Bill aims at making more precise the frontiers
between invention and discovery, when it states that “the object of an
invention involving biological matter cannot be considered a discovery or as
devoid of novelty simply because such matter already existed in Nature”
(Art.8). It must be recalled that discovery is considered to be non patentable,
insofar as Man does not intervene in the modification and utilisation of a
phenomenon that already exists in Nature.
3.
Nevertheless, and as regards inventions (it must be borne in mind that
one of the conditions of eligibility for patent rights is that they apply to
inventions), resulting from a technical process – which result Nature is unable
to obtain through the simple application of its laws – patent rights may be
applied for when these aspects accrue to the other pre-requisites for the
granting of patents.
In fact, this new Bill evidences a strong concern with the clarification of
definitions, since it not only introduces a differentiation between invention and
discovery but also it defines what is meant in this Directive by biological
matter (it must be noted that not all biological matter is living matter), by
microbiological process, and by an essentially biological process of obtaining
plants or animals (Art. 2).
The fundamental alteration, from an ethical point of view, is the
clarification of the conditions of exclusion from patentability of the human
body and its elements, achieved by replacing the expression “as such” with
“the human body and its elements in their natural state" (Art. 3, #1).
Because of its helpfulness in the interpretation of this principle, we
must not fail to refer consideration no.16 of the Bill, which clarifies some
fuzzy situations when it says that “(…) an isolated element of the human
body, or one produced differently, cannot be considered as non patentable in
the same way as an element of the human body in its natural state, that is to
say, it cannot be put on a par with a discovery, for the isolated element
results from technical processes which identified it, purified it, characterised it
and multiplied it outside of the human body, and these processes can only be
carried out by the human being, Nature being incapable of carrying them out
alone.”
R. Prof. Gomes Teixeira, Edifício da PCM, 3º andar, sala 321,
tel. 392.76.88, fax 392.76.15
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CONSELHO NACIONAL DE ÉTICA PARA AS CIÊNCIAS DA VIDA
As mentioned above, one of the pre-requisites underlying the
patentability of an invention is that its exploitation must not run counter to
public order and moral decency.
These pre-requisites are also provided for in the new Bill (Art. 9, #1),
which specifies two cases of non patentability: methods of germinal genic
therapy of the human being and such “processes of modification of the
genetic identity of animals as may cause them suffering or diminishment of
physical capacities without substantial utility for either humankind or the
animal (…)”.
In a previous Opinion, the CNECV has already stated its position on
the admissibility, from an ethical perspective, of granting patents to
alterations of the human genome, that is in the genic therapy of cells of the
germinal line. Human genic therapy is defined as “the deliberate transfer of
genetic material to a patient’s cell with the aim of curing or preventing a
disease”3, saving the fact that it is not yet possible today to remove genes
from cells but only to add them on. Genic therapy on cells of the germinal line
is defined as that which is performed on “spermatozoa or ovules and their
precursory cells as well as those cells of the first stages of the human
embryo”4.
Even though such germinal therapy is expressly forbidden by the
legislation of some countries5, and the Council of Europe itself supports that
position6, this does not mean, contrary to the conclusions of some authors7,
that the present interdiction entails ruling out any future form of utilisation.
As the matter stands, despite the possible future benefits for
Humankind, namely the eradication of genetic diseases, there seems to be a
consensus in the scientific community that the present state of scientific
knowledge does not yet allow conditions of safety nor probabilities of
success. On the other hand, and from an ethical perspective, we are
confronted with the question of knowing whether the principle of human
dignity might not collide with the right of future generations to inherit a genetic
patrimony that has not been manipulated.
A last word about patenting animals and plants, and about the
introduction of the disposition contained in Article 4 of the new Bill. Item 2 of
3
Definitions extracted from the Opinion on Genic Therapy by the Group of Advisors on the Ethical Implications of
Biotechnology (European Commission), 1994.
Cf. the same Opinion mentioned in 3 above.
5
Such as Sweden.
6
Recommendations 934 and 1100.
7
MM. Harold Edgar e Thomas Tursz, Opinion on Human Genic Therapy, UNESCO, op. cit., and Luís Archer, “Genic
Therapy 92”, in Brotéria Genética XIV CLXXXIX, Lisbon 1993, p. 79.
4
R. Prof. Gomes Teixeira, Edifício da PCM, 3º andar, sala 321,
tel. 392.76.88, fax 392.76.15
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CONSELHO NACIONAL DE ÉTICA PARA AS CIÊNCIAS DA VIDA
that Article, especially, by allowing the patentability of plants, animals or parts
thereof obtained through a process that is not essentially biological, seems to
confirm that the exclusion of patents on plant and animal varieties must be
interpreted restrictively. This position seems to confirm, therefore, the
juridical orientation of the European Patent Office, particularly as regards the
patenting of transgenic animals such as the Harvard rat and others.
R. Prof. Gomes Teixeira, Edifício da PCM, 3º andar, sala 321,
tel. 392.76.88, fax 392.76.15
1350 LISBOA
CONSELHO NACIONAL DE ÉTICA PARA AS CIÊNCIAS DA VIDA
CONCLUSIONS:
The considerations above lead us to the following conclusions:
a)
Bearing in mind that certain biotechnological inventions imply
the utilisation of elements of human origin – and that the juridical
protection of such inventions should become effective once they have
been patented – an imperative must be placed on respect for human
dignity and abeyance to the principles that proceed therefrom, to wit,
the non-commercialisation of the human body and the right to free and
informed consent.
b)
In spite of evident benefits to Humankind, powerful economic
motivations also move the biotechnological industry. In this context, it
is urgent to emphasise that the interests and well-being of the human
being must always prevail over the interests of society and Science,
as expressly laid down in the Convention on Human Rights and
Biomedicine of the Council of Europe.
c)
The definition of concepts and the clarification of the cases
where patenting is ruled out are evidence, in the newly submitted Bill,
of commendable progress
d)
On the other hand, there is no sense in the elimination from the
text of the new Bill of the expression “not contrary to the dignity of the
human person”. The expression should be re-introduced in the new
text.
e)
The text of the new Bill is too restrictive when it excludes from
patentability all methods of germinal genic treatment of the human
being. And it is ambiguous in not extending such a restriction to cases
of genetic engineering for genetic improvement, or in eugenic
practises. The CNECV would prefer a text that would not contain a
categorical rejection of genic interventions on cells of the germinal
line, recommending however an interdiction on genic interventions
done merely for the purpose of improvement.
Lisbon, January 8th, 1997
The Reporter,
Dr. Paula Martinho da Silva
The President of the CNECV,
Prof. Dr. Luís Archer
R. Prof. Gomes Teixeira, Edifício da PCM, 3º andar, sala 321,
tel. 392.76.88, fax 392.76.15
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